Events

Rappel de Device Recall Mitek

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par DePuy Mitek, Inc., a Johnson & Johnson Co..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    55877
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2297-2010
  • Date de mise en oeuvre de l'événement
    2010-06-07
  • Date de publication de l'événement
    2010-08-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92128
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Cause
    Product does not meet the required packaging specifications for pouch seal integrity which could lead to a breach in sterility.
  • Action
    The firm, Depuy Mitek, sent an "Urgent Voluntary Product Recall" letter dated June 7, 2010, to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to not use any of the identified recalled products; to isolate all inventory of the affected product; complete the Business Reply Form, and return the affected products along with the form to Depuy Mitek; ATTN: Recall Coordinator, 50 Scotland Boulevard, Bridgewater, MA 02324 or fax completed form to 1-508-828-3750. Note the IMPORTANT PRODUCT INFORMATION: Any product that contains a round green sticker has been 100% inspected, meets specifications and is acceptable for use. Please Do Not Return any product that is labeled with the green dots because this product is not affected by the recall. If you have any questions or concerns with regard to this program, please contact your local Depuy Mitek Representative or DePuy Mitek Customer Service directly at 1-800-382-4682.

Device

Device Recall Mitek
  • Modèle / numéro de série
    All lots of unexpired product
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA and countries including Canada, Argentina, Australia, Bahrain, Belgium, Brazil, Chile, China, Columbia, Costa Rica, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Jordan, Kazakhastan, Kuwait, Lebanon, Maylasia, Mexico, Netherlands, New Zealand, Oman, Pakistan, Palestine, Panama, Peru, Poland, Qatar, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Portugal, Sweden, Switzerland, Syria, Thailand ,Turkey, UK, Ukraine, UAE, Venezuela, Vietnam, and Yemen.
  • Description du dispositif
    Mitek VAPR Temperature Control Electrode (integrated || Product Code: 227252 || The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrodes (S9¿ and S ¿) with Integrated Handpiece with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.
  • Manufacturer
    DePuy Mitek, Inc., a Johnson & Johnson Co.

Manufacturer

DePuy Mitek, Inc., a Johnson & Johnson Co.
  • Adresse du fabricant
    DePuy Mitek, Inc., a Johnson & Johnson Co., 325 Paramount Dr, Raynham MA 02767
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA